MAUDE Adverse Event Report: ZIMMER REVERSE SHOULDER SYSTEM INSTRUMENTATION PIN 2.5MM; PIN, FIXATION, THREADED

Catalog Number 47-4309-025-01

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/10/2017

Event Type  malfunction  

Event Description

The tip of the pin broke off and was embedded in patient's glenoid scapula.Retained.

• Brand Name: REVERSE SHOULDER SYSTEM INSTRUMENTATION PIN 2.5MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): ZIMMER; warsaw IN 46580
• MDR Report Key: 6947537
• MDR Text Key: 89459831
• Report Number: MW5072742
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 47-4309-025-01
• Device Lot Number: 63769461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 107